GxP Lifeline

Med Device Company Takes Flight With Life-Changing Innovation

3 October, 2018 by David Jensen, Staff Writer, MasterControl

EDITOR'S NOTE: This is the first installment of a three-part blog post series about medical device innovator and startup Braveheart Wearable Life Sensors and how automated quality management and compliance solutions have helped the organization take their business to the next level.

“If we all worked on the assumption that what is accepted as true is really true, there would be little hope of advance.” - Orville Wright

As part of the pioneering duo that paved the way for humans to defy gravity, it’s safe to say that Orville Wright was a proponent of advancement. Orville’s inaugural flight aboard the Wright Flyer reportedly lasted 12 seconds. The flight may not have been long enough to wheel out the beverage cart, but that seminal accomplishment galvanized breakthroughs in both aviation and engineering. In many ways, aviation symbolizes life-changing innovation. This three-part article series follows the progression of startup medical device company, BraveHeart, and how the company’s endeavors are inspired by aviation.

The Startup Venue

A startup venture is the embodiment of innovation. Often hitting the ground running with little more than an idea and a vision, startups have the potential for creating something colossal. Traditionally, ventures are usually launched from garages, basements or even the kitchen table. However, Steve McCalmont, founder and CEO of BraveHeart Wearable Life Sensors, prefers a venue that’s more felicitous to the spirit of innovation – an airplane hangar.

As a quintessential entrepreneur and avid small aircraft pilot, McCalmont believes an airplane hangar is an ideal environment for a startup. “I’ve started many successful businesses in a hangar,” he said. “There are a lot of similarities between flying and developing medical devices.”

Who Is Braveheart?

BraveHeart is a startup medical device company developing a wearable body health and biometric sensor, called a Life Sensor. The device’s functionality allows health care providers to monitor a patient’s heart rate, pulse, blood oxygen, skin temperature and more from anywhere in real time.

The Life Sensor is portable and designed to be used in an in-patient or out-patient setting. All the electrodes and monitoring hardware are encapsulated in a small, wireless patch about the size of an adhesive bandage. Using cloud-based, Internet of Things (IoT) technology, the device gathers biometric data from wherever the user is located and sends it to the user’s customized analytics program. The data is converted to clinically actionable information that health care providers can immediately use to diagnose and treat patients.

The Need: Getting Critical Data to Health Care Professionals Faster

The McCalmonts are a multigenerational aviation family. This means they are all required to receive an annual physical as mandated by the US Federal Aviation Administration (FAA). This yearly checkup includes a cardiac stress test, which involves attempting to use a piece of exercise equipment while being tethered to an electrocardiogram (EKG) machine by a mass of electrodes.

During one of his stress tests, McCalmont recalls stepping onto a treadmill with a myriad of wires draped over him. He immediately started giving thought to how the biometric data gathering could be done remotely on a system with fewer tentacles.

The Entrepreneurial Mindset

One perspective about entrepreneurialism is it’s not about what you make, it’s about what you make possible. Steve McCalmont knows how to make an idea a reality. “Suddenly, gathering an array of vital information from a patient in virtually any environment is much easier,” he explained. Further, the Life Sensor’s small size and wireless capabilities make its usage in remote health care scenarios more economically feasible. “Our goal with this device is to save a million lives,” he said.

How Leading-Edge Technology Relates to Aviation

Metaphorically, McCalmont’s view of leading-edge technology goes back to the wings of an airplane. The wings meet the air first, and they are largely responsible for keeping the airplane in the air and moving forward. He believes the processes for designing and developing a medical device resemble the operation of an airplane. The intent of both is to keep moving forward. If the elements of quality, safety and performance are in place, there is no reason to turn back. To ensure that BraveHeart continues to move forward with the Wearable Life Sensor, he insists that quality is inherent throughout the product lifecycle.

No Stranger to Standards of Quality and Compliance

Having built several successful companies, McCalmont has had significant involvement developing products that need to meet standards for product quality, safety and efficacy. The BraveHeart Life Sensor is another such product. Although the Wearable Life Sensor is non-invasive, the device is categorized as a Class II medical device, which means the device needs to achieve regulatory compliance.

Speaking on the realities of a medical device startup, McCalmont advised that there are many choices to make to become successful. He agreed that using digital quality management technology, such as MasterControl Spark, was the best decision for meeting stringent quality and compliance standards and obtaining regulatory approval.

Read part 2 in this article series, where McCalmont illustrates BraveHeart’s approach to quality, safety and efficacy with a demonstration of an aircraft preflight check.

David Jensen is a marketing communication specialist at MasterControl. He has been writing technical, marketing and public relations content in technology, professional development, business and regulated environments for more than two decades. He has a bachelor’s degree in communications from Weber State University and a master’s degree in professional communication from Westminster College.